Recall Z-1473-2011 ยท KPG
GE Healthcare, LLC
GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 Advantage Sim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. D
| Date | Mar 2, 2011 (initiated Nov 24, 2010) |
| Status | Terminated |
| Reason | GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combination with specified other functions of the AdvantageSim application on Advantage Workstation. These inconsistencies may affect patient safety. Other AdvantageSim functions are not affected. |
| Root cause | Software design |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 23, 2010. The letter was addressed to Hospital Administrators / Risk mangers, Oncology Department Managers / Radiation Oncologists, & Radiation Physicists / Dosimetrists / Therapists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For any questions or concerns regarding this recall, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE He |
| Quantity | 1531 |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MI, MN, MS,MO, NT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARA |
| FDA record | Open on fda.gov |